Binary fluid control valve system

ABSTRACT

Fluid control valves including single-opening, binary fluid control valves that are initially closed and can be opened one time only to allow a fluid transfer between two spaces separated by a fluid impermeable barrier. Applications of valves of this type include inflatable devices, including but not limited to medical device balloons, in particular gastric balloons for weight loss.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a non-provisional of U.S. Provisional applicationNo. 62/694,813 filed on Jul. 6, 2018, the entirety of which isincorporated by reference.

BACKGROUND OF THE INVENTION

The present invention generally relates to the field of fluid controlvalves and more particularly the field of single-opening, binary fluidcontrol valves that are initially closed and can be opened one time onlyto allow a fluid transfer between two spaces separated by a fluidimpermeable barrier. Areas of application for valves of this typeinclude medical device balloons, in particular gastric balloons forweight loss.

According to 2010 World Health Organization data, 198 million Americansover the age of 15 are above target weight. Of these individuals, 89million are considered overweight (25<Body Mass Index<30) and 109million are considered obese (Body Mass Index>30). Worldwide, more than1.4 billion adults age 20 and over are overweight, and 500 million areobese. Obesity places patients at increased risk of numerous,potentially disabling conditions including type 2 diabetes, heartdisease, stroke, gallbladder disease, and musculoskeletal disorders.Compared with healthy weight adults, obese adults are more than threetimes as likely to have been diagnosed with diabetes or high bloodpressure. In the United States it is estimated that one in fivecancer-related deaths may be attributable to obesity in femalenon-smokers and one in seven among male non-smokers (>=50 years of age).On average, men and women who were obese at age 40 live 5.8 and 7.1fewer years, respectively, than their healthy weight peers.

For the vast majority of the overweight and obese population for whomsurgical obesity procedures are not appropriate, few efficacious andaffordable interventions are currently available. Diet and exerciseremain the front line approaches to obesity, however this approach hasat best slowed the growth of the epidemic. To date, drug therapies havedose limiting side effects or have lacked meaningful long term efficacy.

One less-invasive intervention that has begun to gain popularity is anintragastric balloon. Intragastric balloons in their uninflated statecan be placed endoscopically or positioned using other methods and, oncein place, are typically filled with a filling fluid through a thincatheter or conduit extending up the esophagus from the device in thestomach to an external fluid supply. This catheter is then removed fromthe device and extracted from the body through the esophagus. Uponremoval of the catheter, the catheter system must seal the fluidcommunication between the interior of the device and the gastricenvironment to maintain the balloon in its filled state for theproscribed time.

In some gastric balloons an endoscopic procedure is used to remove theballoon at the end of its proscribed time. Endoscopic procedures, whilegenerally safe, inherently carry some risk to the patient, are invasive,require the patient to visit an endoscopy facility, and require theservices and costs of an endoscopist. For these reasons variousself-opening or non-invasively-triggered fluid release mechanisms orvalves have been developed.

In particular, several self-opening release valves, as described in thefollowing commonly assigned patents, publications, and provisionalapplications: U.S. Pat. No. 8,814,898 (ALLR-N-Z003.01-USS); U.S. Pat.No. 8,870,907 (ALLR-N-Z003.00-USX); U.S. Pat. No. 8,974,483(ALLR-N-Z004.00-USS); U.S. Pat. No. 9,387,107 (ALLR-N-Z003.02-USS); U.S.Pat. No. 9,827,129 (ALLR-N-Z003.03-USS); U.S. Pat. No. 9,849,018(ALLR-N-Z020.00-USS); U.S. 20150196408 (ALLR-N-Z004.01-USS); U.S.20180042747 (ALLR-N-Z003.04-USS); U.S. 20180071127 (ALLR-N-Z020.01-USS);U.S. 20180168839 (ALLR-N-Z026.00-US); and Provisional Application Nos.62/562,882, 62/635,272. The entirety of each of which is incorporated byreference herein. In addition, the valves described herein can be usedwith the devices described in the forgoing patents, publications andprovisional applications.

However, in certain applications there may be a need for a device torapidly deflate. Therefore, there remains a need for devices where afluid release flow rate is increased to assist with fast deflation ofthe device. For instance, there also remains a need for a self-releasingvalve that opens rapidly to its full open state.

SUMMARY OF THE INVENTION

The present invention relates to devices and methods for releasing afluid from a reservoir. In particular, the invention relates toself-opening release valves for emptying balloon-like devices. Moreparticularly the invention relates to self-opening valves that openrapidly after initiation of the opening process, where self-openinggenerally implies no direct human action. In some variations, the valvescan achieve full aperture opening in a rapid manner.

The present disclosure includes fluid release mechanisms for use withfluid filled devices and are especially useful in gastric balloons foroccupying a space within the patient's body. In one example such amedical device includes a fluid impermeable surface material forming adevice body having an interior reservoir, the device body having adeployment profile and expandable to an active profile upon receivingthe fluid filler material within the interior reservoir; a fluid pathfor evacuation of the fluid, a plug for sealing the fluid path, anenergy storage element disposed to remove the plug from the fluid path,and a release material disposed to hold the plug in a sealingconfiguration in the evacuation path until the strength of the releasematerial degrades below that which is needed to resist the energystorage element.

The above and other features of the invention including various noveldetails of construction and combinations of parts, and other advantages,will now be more particularly described with reference to theaccompanying drawings and pointed out in the claims. It will beunderstood that the particular method and device embodying the inventionare shown by way of illustration and not as a limitation of theinvention. The principles and features of this invention may be employedin various and numerous embodiments and variations without departingfrom the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of the methods,devices, and systems described herein will become apparent from thefollowing description in conjunction with the accompanying drawings, inwhich reference characters refer to the same parts throughout thedifferent views. The drawings are not necessarily to scale; emphasis hasinstead been placed upon illustrating the principles of the invention.Of the drawings:

FIG. 1 is a block diagram of a fluid fillable balloon device.

FIG. 2 illustrates a gastric balloon in situ after filling.

FIG. 3A is a mechanical schematic showing the functional elements of afluid control valve system, shown in its normally closed state.

FIG. 3B is a mechanical schematic showing the fluid control valve systemof FIG. 4A in its opened state after the stored energy has beenreleased.

FIGS. 3C-3G are alternative mechanical schematics of the fluid controlvalve system

FIG. 4 is an exploded perspective view of a variation of a fluid controlvalve with an external energy storage device.

FIG. 5A is a sectional view of the fluid control valve of FIG. 4 asinstalled in a wall of thin film material.

FIG. 5B is an exploded view of one variation of a socket assembly.

FIG. 6 illustrates a perspective view of the fluid control valve as aplug is being inserted into a socket assembly.

DETAILED DESCRIPTION OF THE INVENTION

The following illustrations are examples of the invention describedherein. It is contemplated that combinations of aspects of specificembodiments or combinations of the specific embodiments themselves arewithin the scope of this disclosure. While the methods, devices, andsystems described herein are discussed as being used in conjunction witha gastric balloon device, the devices, methods, and systems of thepresent disclosure can be can be used with other fluid-filled devices orsystems where automatic release of the fluid in the device or systemmight be required or beneficial or where automatic release of the fluidbetween any two separated spaces in which unassisted (that is, withoutdirect human manipulation or intervention) opening of a fluid passagebetween the two spaces is desired.

FIG. 1 illustrates schematic block diagram of an exemplary fluidfillable balloon device; in particular, it illustrates a gastric balloondevice assembly 100. FIG. 2 is an illustration of device 100 in place ina patient's stomach after it has been inflated but before the fillingtube has been removed. The device generally comprises two states ofinterest: a pre-deployment or uninflated configuration and a deployed,inflated or active configuration; the deployed configuration is shown.Generally, the device is inflated with a fluid delivered through a tube110, also referred to herein as a catheter or conduit, wherein the tubemay pass through a lumen in the wall of the balloon device or is coupledto a fluid path 112 between the exterior and the interior of the balloondevice. In certain balloon devices the wall 102 of the balloon isfabricated from a thin film material such as, for example, polyurethane.In some variations the tube comprises a balloon end or internal section110A that extends through fluid path 112 into the central enclosed spaceor reservoir 104 of device 100. In other variations internal section110A stops short of the reservoir 104. The conduit 110 can be removedfrom the device once inflation is completed or after partial inflation.When the conduit is removed, fluid path 112 must be sealed to preventthe inflation fluid from leaking out, where sealing is accomplished byfill valve 113, illustrated in FIG. 1, which may comprise an externalsection 113B, an internal section 113A. In some variations, elements ofthe fill valve 113 have components installed inside conduit 110 as wellas in fluid path 112. Other variations of the balloon device may beself-inflating, wherein, for example, two reactive chemicals pre-storedinside the uninflated balloon combine once the balloon is in place. Thecombined materials, such as an acid and bicarbonate of soda, give off agas that inflates the balloon.

It is typically the case that release valve 126 is a single-use device;that is, once it opens to release fluid it cannot close, or at least isnot closed, again. In some variations, as illustrated in FIG. 2, thevalve may comprise a patch 128 of degradable material, which degrades oropens when exposed to either the natural stomach fluids or the fillingfluid contained within reservoir 104. Once patch 128 degrades, thefilling fluid is free to escape into the patient's stomach. In certaincases, the degradation rate of the patch, and the resulting flow rate,cannot be controlled adequately. The release valves described hereinimprove the timing and adequacy of the flow rate of the release offiller fluids by controlling the degrading fluid and by providing a

FIG. 3A is an exemplary mechanical schematic diagram of a fluid controlvalve system 10 that has a binary flow condition or operation, where“binary” indicates that the valve comprises an open state and a closedstate. Where in the closed state the valve is closed to either fully orsignificantly prevent fluid flow. In the open state, the valve allowspartial or maximum fluid flow. It will be understood that a mechanicalschematic diagram is a simplified representation of the functionalcomponents of a mechanical system and the mechanical relationshiptherebetween. It does not necessarily represent the physical forms ofthe mechanical elements nor the physical layout, attachment, orconfiguration of any actual components.

Returning to FIG. 3A, the binary operation of control valve system 10 isachieved through the addition of an energy storage device disposed toforce the valve to the fully open condition, a valve system 10 isdisposed between two otherwise isolated spaces, spaces 510 and 520, atleast one of which contains a fluid 415A. In some variations the secondspace also contains a fluid 415B. In this variation, a valve system 10includes three core mechanical components. The main component is a valvemechanism 410 that blocks or unblocks the flow of fluid from one spaceto the other. Schematically in FIG. 3A valve mechanism 410 is depictedas comprising a two element gate (412, 414), where one element of thegate is a base 414 and a second element is a traveler 412 where traveler412 and base 414 abut tightly enough to block the flow of any fluid415A/415B through valve mechanism 410. Note again that a mechanicalschematic only represents functional elements and is not intended toindicate the physical form of the element effecting that function.

As further illustrated, valve system 10 comprises a second corecomponent, an energy storage device 420, for example a spring, where theenergy storage device is disposed to move traveler 412 away from base414. In the schematic a base support 416 and a head 418 have beenincluded to schematically illustrate a connection between energy storagedevice 420 and valve mechanism 410. In the normal operation of valvesystem 10, energy storage device 420 is initially in a high energystorage configuration and disposed between head 418 and base support 416with a distance D1 between head 418 and base support 416. The compressedenergy storage device 420 generates a force F directed to push traveler412 away from base 414, as indicated by the arrowheads at the ends ofspring 420. Energy storage device 420 does not need to be attached toeither head 418 or base support 416 (or, equivalently base 414 ortraveler 412). Alternatively, one or both sides of the device can beconnected to the respective adjacent head 418 or base support 416.

The third core component of a valve system 10 is a restraining element425. Under normal initial operation of valve system 10, restrainingelement 425 is also disposed between head 418 and base support 416,where restraining element 425 is in tension T which holds head 418 andbase support 416 from moving apart, as indicated by the arrowheadsshowing the forces felt by head 418 and base support 416.

Valve system 10 switches between the no-flow condition, shownschematically in FIG. 3A, and the full-flow condition, shownschematically in FIG. 3B, when restraining element 425 loses its abilityto counteract the force F of energy storage device 420. Depending on thedesigner's needs, restraining element 425 can be designed to losestrength by changing its temperature, by hydrolysis, by dissolution, byoxidation, or by any means appropriate for the restraining material andoperational environment. Typically restraining element 425 breaks whenthe spring force exceeds the remaining strength of element 425, asillustrated in the figure, but element 425 may also lose its ability tomaintain the required tension if it plasticly deforms, that is,stretches permanently, or elastically deforms.

As shown in FIG. 3B, the failure of restraining element 425 allowsenergy storage device 420 to increase the distance between base support416 and head 418 to D2, thereby allowing fluid flow through valvemechanism 410 as shown by the arrows. In FIG. 3B, head 418, traveler412, and a portion of restraining element 425 no longer have aconnection to base support 416 indicating that those parts of fluidcontrol valve system 10 are free to float away by a distance greaterthan D2. In other variations energy storage device 420 may be attachedto head 418 instead of base support 416 while in yet other variationsenergy storage device 420 may connect head 418 and base support 416 evenafter opening, in which case D2 is the length of energy storage device420 in its low energy condition (e.g., no longer in compression). In yetother variations energy storage device 420 is not physically attached toeither base support 416 or head 418, in which case it may become afree-floating element once the constraining tension of restrainingelement 425 is removed.

As was noted above, mechanical schematic diagrams are not intended tosuggest or describe actual embodiments of the mechanical system; theyonly explain the mechanical functional relationships in the mechanicalsystem. For example, FIGS. 3C, 3E, and 3F are alternative mechanicalschematics of the same fluid control valve system as depicted in FIG.3A. FIG. 3C illustrate a variation in which base 414 and traveler 412sandwich energy storage device 420 between themselves directly (that is,the spring sits between the two portions and directly bears on them tomove them apart) while restraining element 425 is directly or indirectlyattached to the exterior of the “sandwich” to hold base 414 and traveler412 tightly together, compressing energy storage device 420. Themechanical schematic of FIG. 3D illustrates the after-release mechanicalrelationships of the elements in the schematic of FIG. 3C.

FIG. 3E illustrates schematically a variation of the valve system inwhich base 414 is in the form of a fluid path 450 which channels fluid415 between the isolated spaces 510, 520. Traveler 412 forms a plug orstopper that blocks fluid path 450 when the valve system is in itsnormally closed condition. Drawn in this fashion, the mechanicalschematic of FIG. 3E helps clarify the use of a control valve system 10in fluid filled balloon applications an embodiment of which is discussedbelow.

In some variations of control valve system 10 it is possible to combinetwo or more functions into one physical element. As shown schematicallyin FIGS. 3F and 3G, in this variation the base, traveler, andrestraining element are all embodied in a single close-ended tube 530.Initially, tube 530 is a sealed fluid path between spaces 510 and 520.

Energy storage device 420 is disposed to apply a force that is directedto pull the two ends 412, 414 of tube 530 apart. The two ends do notmove apart while the walls of tube 530 remain strong enough to withstandthe applied force. When the restraining element loses strength, as it isdesigned to do in specific environments, it will eventually allow thespring to pull tube 530 into two pieces, forming traveler 412 and base414 and essentially allowing flow through the base support 416, as shownin FIG. 3G.

In yet another variation of valve system 10, not illustrated, base 414and traveler 412 may comprise two jaws of a hinged component, withenergy storage device 420 acting to open the hinge and restrainingelement 425 holding the hinge closed until element 424 loses strength asdesigned.

Other variations, also not illustrated, include energy storage devicesin which the energy is stored by holding the device in an expanded,rather than compressed state.

Exterior Energy Storage Device

FIG. 4 is an exploded view of one variation of valve system 10 with anexterior energy storage device 420 in the form of a coil spring, whereexterior indicates the spring 420 is exterior to the flow path throughthe valve system 10. In this variation, valve 410 of FIG. 3A comprisestraveler 412 in the form of a plug or pin, base 414 in the form of asocket into which plug 412 is inserted, and a compliant gasket 427 thatsurrounds plug 412 to ensure a snug and leak-proof fit when plug 412 isinserted into socket 414.

As further illustrated in FIG. 4 and sectional view FIG. 5A, thisvariation of valve system 10 also comprises energy storage device 420implemented as a coil spring disposed between a spoked head 418 and asubstantially identical spoked base support 416, wherein restrainingelement 425 is a suture-like release material that is looped or stitchedbetween the spokes of head 418 and base support 416. Head 418 and basesupport 416 each have a central hole large enough to accommodate plug412 surrounded by gasket 427. In this variation release material 425 isstitched in a pattern to minimize tilting of head 418 relative to basesupport 416 both before and after initial release material breakdown.

As shown in the figures, in this variation plug 412 comprises anextended body 412A with a larger diameter pinhead 412B at one end, wherethe length of the extended body is designed to be longer than the lengthof the compressed coil spring 420 plus the thicknesses of the head 418and base support 416, and the diameter of pinhead 412B is designed to belarger than the hole in head 418 to prevent plug 412 from fully enteringor passing through the hole in head 418. The spring, head, base support,and release material comprise a valve release subassembly 440.

In this variation socket 414 is essentially a cylindrical tube disposedbetween the two spaces comprising a central lumen that allows fluid flowbetween the two spaces. In many variations socket 414 is fabricated as asocket subassembly 442 that allows the socket to be attached to the wall102 separating the two spaces, as will be described below.

This variation of valve system 10 is assembled by inserting plug 412(with gasket 427), through the lumen in valve release subassembly 440formed by the open central region of coiled spring 420 such that a tip419 of plug 412 extends beyond the end of valve release subassembly 440by a designed length. As further illustrated in FIGS. 4 and 5A, theexposed tip 419 of plug 412, surrounded by gasket 427, is subsequentlyinserted into socket subassembly 442, where the gasketed tip 419 sealsthe lumen in socket subassembly 442 against fluid flow. In somevariations tip 419 of plug 412 is bulbous to compress gasket 427 againstthe innermost surface of socket assembly 442 while providing a leadingedge that guides tip 419 into the lumen.

As shown in FIG. 5A and in perspective view in FIG. 6, valve system 10can be installed to control fluid flow between two spaces separated by awall 102 of thin film material. While FIGS. 1 and 2 suggest the use of avalve system 10 to release fluid from a gastric balloon fabricated fromthin film material, this is but an exemplary use. The valves describedherein may be used in any situation where there is a fluid imperviousbarrier material separating two spaces and where fluid may be present oneither or both sides of the barrier material. For example, a valvesystem 10 can be used to temporarily separate two reactive chemicalswhere one chemical is in fluid form.

As illustrated in FIG. 5B, socket subassembly 442 is attached to wall102, through which a hole is provided for fluid flow. There are severalways to attach socket subassembly 442 to a wall, for example gluing orwelding, where the preferred method of attachment is an engineeringdecision based, among other considerations, the material properties ofwall 102 and socket assembly 442. In the illustrated variation, wherewall 102 is a thin polymeric sheet, mechanically attaching socketassembly 442 is used for example. In this variation socket assembly 442comprises three parts: a retaining ring 444, a wall anchor 310, and agasket jacket 210.

Gasket jacket 210 is a thin-walled, hollow cylinder. The inner wall ofthe hollow cylinder is sized, and sometimes shaped, to grip thecompliant, gasketed tip 419 of plug 412. For example, the inner wall maybe tapered to have a wider opening to accept plug 412 and to guide thetip 419 into a narrower portion wherein the compliant gasket is squeezedto make a tight fit. The inner wall may be inscribed with a number ofcircumferential ridges and grooves to better grip the compliant gasket.Or for example, in some variations, the inner wall may have an indentedgroove with a circular segment cross-section that matches the bulboustip 419 of the gasketed plug; this groove acts a detent to provide apositive hold on tip 419.

Wall anchor 310 is the primary means to attached gasket jacket 210 to athin-film wall 102. It is used to pinch a shaped section of wall 102against the exterior of gasket jacket 210. This pinching behavior isillustrated in the exploded, cross sectional view of socket assembly 442of FIG. 5B. The wall section starts out as a flat sheet but takes on theillustrated “stovepipe hat” shape after being stretched over a mandrel.Gasket jacket 210 is then inserted inside the wall section, most easilyfrom the “brim” side of the stovepipe hat while wall anchor 310 isslipped over the exterior of the “pipe” section of the stovepipe,thereby trapping the wall material between jacket 210 and anchor 310. Inmany variations anchor 310 is fabricated from a soft material, forexample a plastic, and toleranced to enclose the wall material withoutpulling or tearing it. Finally, a retaining ring 444 is placed overanchor 310 to squeeze it tightly against wall material 102, pinching thematerial against gasket jacket 210.

FIG. 6 illustrates one method for inserting plug 412 (with valve releasesubassembly 440 in place) into a socket assembly 442 that has beenpre-installed in a wall 102. As shown, gasket 427 is extended by aconvenient length to form a gasket extension 427A that extends aconvenience distance beyond plug tip 419. This extended length 427A isnot filled by any solid and can easily be threaded through the lumen ingasket jacket 210. A portion 427B of gasket extension 427A emergesthrough the lumen in gasket jacket 210 on the opposite side of wall 102from plug 412. Gasket extension 427A moves with relative ease throughgasket jacket 210 because there is no plug inside this portion of thegasket. Tip 419 of plug 412 is drawn into gasket jacket 210 by pullingon gasket extension 427B until tip 419 is captured by jacket 210. Bydesign, tip 419 and the gasket around it cannot pass fully through thelumen, so continuing to pull on gasket extension 427B creates anincreasing tension on gasket 427.

When the elastic limit of gasket 427 is reached, the gasket tears intotwo sections. In some variations a preferential detachment point 429 iscreated in gasket 427 by weakening the gasket at a pre-determinedlocation by partially cutting through the gasket, creating acircumferential score, or otherwise weakening the gasket at the desiredlocation. Typically, the desired location separates gasket 427 fromgasket extension 427A. Using a preferential detachment point created byweakening the gasket allows the designer to control how much force isrequired to tear the gasket, where the tear will be, and ensure a cleantear between the removed portion of the gasket and the gasketsurrounding tip 419 to seal the valve.

For the illustrated variation, the valve is installed in a fluidimpervious wall 102 separating two spaces on either side of the wall,where at least one space has a fluid. Plug 412 substantially fills thelumen in gasket jacket 210 and presses gasket 427 against the inner wallof the lumen in gasket jacket 210 to seal the lumen against fluidtransfer. For convenience, the space in which release valve subassembly440 is located will be designated as first or interior space and isbounded by wall 102. By design, release material 425 is susceptible todeterioration when exposed to the environmental conditions in theinterior space. In many variations the release material is filamentary.Examples of release materials that are available in filamentary sutureform can include Polyglycolide (PGA), Polydioxanone (PDS),Poly(lactic-co-glycolic acid) (PLGA), Polylactide (PLA), Poly(4-hydroxybutyric acid) (P4HB), Polyglactin 910, and Polycaprolactone(PCL). In some variations the interior space may be filled with a fluidwhich, over a designed period of time, dissolves or hydrolyses thesuture. In other variations, for example, release material 425 may bemelted or softened by increasing the temperature in the interior space.

Independent of the way release material 425 is weakened, after adesigned time period the residual strength of release material 425 isinadequate to constrain the stored energy in spring 420. As spring 420expands it causes head 418 and base support 416 to separate. Bydefinition, as they separate the distance between them enlarges. Priorto release material deterioration, extended body 412A reached betweenthe top of head 418, through base support 416, and into socket 414. Asthe distance between head 418 and base support 416 increases, extendedbody 412A is pulled into valve release subassembly 440 from the basesupport end, plug 412 being prevented from entering head 418 by pinhead412B. As extended body 412A is pulled into valve release subassembly 440it is automatically extracted from socket 414, opening fluid controlvalve system 10 to allow fluid transfer between the interior space and asecond or exterior space exterior to the wall 102.

What is claimed:
 1. A fluid control valve for controlling fluid flow,the fluid control valve comprising: a base defining a fluid paththerethrough such that the fluid path is fluidly coupled between a firstspace and a second space; a traveler structure moveable relative to thebase between an open configuration and a closed configuration, where inthe open configuration the traveler structure permits fluid flow throughthe fluid path between the first space and the second space, and wherein the closed configuration the traveler structure prevents flow throughthe fluid path; an energy storage device disposed between the travelerstructure and the base; a restraining element that restrains the energystorage device in a stored energy condition where the traveler structureis in the closed configuration, where the restraining element isconfigured to degrade such that degradation of the restraining elementreleases the energy storage device from the stored energy condition tocause the traveler structure to move to the open configuration relativeto the base, wherein the restraining element is configured to reduce ina mechanical integrity over a pre-determined period during exposure toenvironmental conditions.
 2. The fluid control valve of claim 1, whereinthe restraining element is configured to degrade in response totemperature change, hydrolysis, dissolution, or oxidation.
 3. The fluidcontrol valve of claim 1, wherein the restraining element is configuredto degrade in response to a fluid in fluid communication with therestraining element.
 4. The fluid control valve of claim 1, where therestraining element is located in the first space and is isolated fromthe second space.
 5. The fluid control valve of claim 1, where therestraining element is located in the second space and is isolated fromthe first space.
 6. The fluid control valve of claim 1, where therestraining element is located outside of the fluid path.
 7. The fluidcontrol valve of claim 1, where the restraining element forms a portionof the fluid path.
 8. The fluid control valve of claim 1, where therestraining element is located within the fluid path.
 9. The fluidcontrol valve of claim 1, where the traveler structure comprises abinary configuration when in the open configuration or in the closedconfiguration, such that the fluid control valve comprises a binaryfluid control valve.
 10. The fluid control valve of claim 1, wherein thetraveler structure and the restraining element comprise a single part.11. The fluid control valve of claim 1, where the traveler structureseparates from the restraining element upon degrading to release theenergy storage device from the stored energy condition.
 12. A fluidcontrol valve for controlling fluid transfer between a first space and asecond space on either side of the fluid control valve, comprising: aplug receptacle installed in a wall separating the first space from thesecond space, the plug receptacle providing a lumen along a length ofthe receptacle that forms a fluid path between the first space and thesecond space, the lumen having a cross-sectional shape with internal,cross-sectional dimensions; a fluid plug having a capping end, aninsertion end, and an extended body running therebetween, where thefluid plug has a cross-sectional shape and outer dimensions configuredto form a fluid seal when the extended body and insertion end areinserted into the plug receptacle; a plug extraction head at the fluidplug capping end; a reaction force head disposed exterior to the plugreceptacle and further disposed towards the insertion end relative tothe plug extraction head; an energy storage device disposed between theplug extraction head and the reaction force head and further disposed toincrease a separation between the plug extraction head and the reactionforce head when in an unconstrained state; a release material attachingthe plug extraction head to the reaction force head and causing theenergy storage device to be in a constrained state; wherein a reductionin a mechanical integrity of release material causes the energy storagedevice to assume the unconstrained state, which applies a force toincrease the separation between the plug extraction head and thereaction force head, and where motion of the reaction force head is atleast initially constrained, directing the force towards the plugextraction head, whereby the fluid plug is extracted from the plugreceptacle.
 13. A fluid control valve for controlling fluid flow, thefluid control valve comprising: a base defining a fluid paththerethrough such that the fluid path is fluidly coupled between a firstspace and a second space; a traveler structure moveable relative to thebase between an open configuration and a closed configuration, where inthe open configuration the traveler structure permits fluid flow throughthe fluid path between the first space and the second space, and wherein the closed configuration the traveler prevents flow through the fluidpath; an energy storage device disposed between the traveler structureand the base; a restraining element, located outside of the fluid pathand that restrains the energy storage device in a stored energycondition where the traveler structure is in the closed configuration,where the restraining element is configured to degrade when in fluidcommunication with a fluid such that degradation of the restrainingelement releases the energy storage device from the stored energycondition to cause the traveler structure to move to the openconfiguration relative to the base.
 14. The fluid control valve of claim13, where the restraining element is located in the first space and isisolated from the second space.
 15. The fluid control valve of claim 13,where the traveler structure comprises a binary configuration when inthe open configuration or in the closed configuration, such that thefluid control valve comprises a binary fluid control valve.
 16. A fluidcontrol valve for controlling fluid flow, the fluid control valvecomprising: a base defining a fluid path therethrough such that thefluid path is fluidly coupled between a first space and a second space;a traveler structure moveable relative to the base between an openconfiguration and a closed configuration, where in the openconfiguration the traveler structure permits fluid flow through thefluid path between the first space and the second space, and where inthe closed configuration the traveler structure prevents flow throughthe fluid path; an energy storage device disposed between the travelerstructure and the base; a restraining element having a strength thatrestrains the energy storage device in a stored energy condition whenthe traveler structure is in the closed configuration, where therestraining element is configured to degrade to a reduced strength,wherein the restraining element is unable to restrain the energy storagedevice which causes the energy storage device to exert a force on thetraveler structure to move the traveler structure relative to the baseto the open configuration.
 17. The fluid control valve of claim 16,wherein the restraining element is configured to degrade in response totemperature change, hydrolysis, dissolution, and oxidation.
 18. Thefluid control valve of claim 16, wherein the restraining element isconfigured to degrade in response to a fluid in fluid communication withthe restraining element.
 19. The fluid control valve of claim 16, wherethe restraining element is located in the first space and is isolatedfrom the second space.
 20. The fluid control valve of claim 16, wherethe restraining element is located outside of the fluid path.
 21. Thefluid control valve of claim 16, where the restraining element islocated within the fluid path.
 22. The fluid control valve of claim 16,where the traveler structure comprises a binary configuration when inthe open configuration or in the closed configuration, such that thefluid control valve comprises a binary fluid control valve.
 23. Thefluid control valve of claim 16, wherein the traveler structure andrestraining element comprise a single part.
 24. The fluid control valveof claim 16, where the traveler structure separates from the restrainingelement upon degrading to release the energy storage device from thestored energy condition.